Pharmacovigilance activities refer to the monitoring, identification, assessment and control of adverse drug reactions and other harmful reactions related to drug use.
Gedeon Richter is committed to treating pharmacovigilance as a high-priority area, aimed to minimize drug safety risks, protect and promote public health and to comply with relevant regulations and directives. The company operates a pharmacovigilance system with quality assurance, which monitors any change in the benefit-risk ratio of medicines throughout their life cycle and informs authorities, healthcare professionals as well as patients of such a change.
Richter has been using an IT system complying with international standards to support the collection, transmission and analysis of information. Continuous monitoring is performed in line with the pharmaceutical authorities, and the information is mutually shared in compliance with our statutory obligations.
The purpose of data collection and analysis is to identify the safety profile of medicines as accurately as possible so as to ensure that the use of the products is targeted as precisely as possible in terms of both indication and target population, primarily through improving the summaries of product characteristics and patient information leaflets. The system is also designed to alert and intervene if it detects a change in the product’s safety or can anticipate any circumstance that may expose society to an unforeseen risk.
Although no medicine is free of side effects, we believe that our activities, aimed at gaining the most precise understanding of the risk-benefit ratio of our medicines, protect both our patients and our products. Our company commit to perform our activity subject to quality assurance standards, in accordance with internationally accepted principles of Good Pharmacovigilance Practice.